TRANXENE T-TAB tablets contain either 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium for oral administration. Inactive ingredients for.
Tranxene T-TAB Tablets (clorazepate dipotassium) Tablets, USP.
Patients taking TRANXENE tablets should be cautioned against engaging in hazardous occupations requiring mental alertness, such as operating dangerous machinery including motor vehicles.
Because of the lack of sufficient clinical experience, TRANXENE tablets are not recommended for use in patients less than 9 years of age.
The maximum recommended total daily dose is 90 mg. Avoid excessive reductions in the total amount of drug administered on successive days.
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc.
Clorazepate (marketed under the brand names Tranxene and Novo-Clopate), also known as clorazepate dipotassium, is a benzodiazepine. It possesses anxiolytic, anticonvulsant, sedative, hypnotic, and skeletal muscle relaxant properties.
Ther., 4, 239 (1969). Siou, Chim. G.
Clorazepate produces the active metabolite desmethyl-diazepam, which is a partial agonist of the GABA A receptor and has a half life of 20 – 179 hours; a small amount of desmethyldiazepam is further metabolised into oxazepam. Other classical benzodiazepines include chlordiazepoxide, diazepam, clonazepam, oxazepam, lorazepam, nitrazepam, bromazepam and flurazepam.
Treating anxiety disorders, certain types of seizures, and symptoms of alcohol withdrawal. Check with your health care provider before you start, stop, or change the dose of any medicine. You may have an increased risk of serious side effects.
This is known as DEPENDENCE or addiction. Some people who use clorazepate for a long time may develop a need to continue taking it. People who take high doses are also at risk.
If you have questions about side effects, contact your health care provider. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA. Call your doctor for medical advice about side effects. This is not a complete list of all side effects that may occur.
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Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urination or change in the amount of urine produced; double vision; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening seizures; slurred speech; suicidal thoughts or actions; tremor; trouble sleeping.
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Clorazepate is also used along with other medications to treat certain types of seizures. It is also used to relieve unpleasant symptoms that may be experienced by people who have stopped drinking alcohol after drinking large amounts for a long time. Clorazepate is in a class of medications called benzodiazepines.
Drinking alcohol or using street drugs during your treatment with clorazepate also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol or use street drugs during your treatment.
Duplication for commercial use must be authorized by ASHP. The American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland. AHFS Patient Medication Information., 2017.
Your doctor will order certain lab tests to check your body's response to clorazepate.
Name, Clorazepate. Accession Number, DB00628 (APRD00881). Type, Small Molecule. Groups, Approved, Illicit. Description. A water-soluble benzodiazepine.
For the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Also used as adjunctive therapy in the management of partial seizures and for the symptomatic relief of acute alcohol withdrawal.
The drug is metabolized in the liver and excreted primarily in the urine.
The protein binding of nordiazepam in plasma is high (97-98%).
Rapidly absorbed following oral administration (bioavailability is 91%).
Oral LD 50 in rats is 1320 mg/kg. In monkeys, oral LD 50 exceed 1600 mg/kg.